*Agnieszka Swidnicka-Siergiejko1, Eugeniusz Wroblewski1, Hady Razak Hady2, Andrzej Dabrowski1
The current place of intragastric balloon in the treatment of obesity – what should clinicians know?
Aktualne miejsce balonu dożołądkowego w leczeniu otyłości – co powinni wiedzieć lekarze?
1Department of Gastroenterology and Internal Medicine, Medical University of Bialystok, Poland
21st Clinical Department of General and Endocrine Surgery, Medical University of Bialystok, Poland
Istniejącą lukę w leczeniu otyłości, pomiędzy standardowym postępowaniem zachowawczym a chirurgią bariatryczną, wypełniają metody endoskopowe, w tym balon dożołądkowy (ang. intragastric balloon – IGB). Aktualnie zatwierdzone przez FDA są trzy balony dożołądkowe: OrberaTM Intragastric Balloon System, ReShape Integrated Dual Balloon System oraz Obalon. Pomimo korzyści wynikających z terapii IGB, takich jak: zachowanie anatomii, potencjalnie mniejsze ryzyko poważnych powikłań i niższe koszty w porównaniu z leczeniem chirurgicznym, osiągany spadek masy ciała jest mniejszy i często tymczasowy. Maksymalną skuteczność z terapii IGB może zapewnić jedynie kompleksowe leczenie obejmujące również edukację pacjenta i zmianę stylu życia. Aby zmniejszyć częstość powikłań i poprawić bezpieczeństwo procedury należy ostrożnie selekcjonować chorych do IGB, przeprowadzać częste kontrole po założeniu balonu i usunąć go we właściwym czasie. W artykule przedstawiamy aktualne dane o zastosowaniu IGB w leczeniu otyłości ze szczególnym uwzględnieniem korzyści i bezpieczeństwa ich stosowania, ostatnich doniesień FDA oraz najnowszych badań.
Endoscopic bariatric therapy (EBT), including intragastric balloon (IGB), seem to fill the gap between medical and surgical options of obesity treatment. Currently, there are three IGB systems approved by the FDA: OrberaTM Intragastric Balloon System, ReShape Integrated Dual Balloon System, and the Obalon system. Despite the advantages of IGB such as anatomy preservation, potentially lower risk of serious complications, and costing than bariatric surgery, the achieved weight loss is smaller and often only temporary. The maximum efficacy of IGB therapy is achieved with a comprehensive weight management program including patient education and lifestyle modification. Careful selection of patients for IGB, frequent control visits after balloon placement, and its removal at 6 months on time after insertion are recommended to reduce complications and increase the safety profile of IGB therapy. We discuss the current place of IGBs in the treatment of obesity with particular focus on their efficacy and safety, recent FDA updates, and published data in order to facilitate future decisions on implementing EBT for individual patients.
Considering the increasing worldwide number of obese and overweight patients as well as obesity-related complications, there is a need for therapies that will provide long-term weight loss. To date, standard treatments of obesity that include diets, physical activity, and pharmacology have had limited efficacy. Currently, bariatric and metabolic surgery remains the most effective method to achieve and maintain weight loss. Bariatric surgery is mainly reserved for patients with a body mass index (BMI) ≥ 40 or ≥ 30 kg/m2 with comorbidities. Overall, the rate of serious complications associated with bariatric surgery is 4% and mortality rate is around 0.1% (1). However, less than 2% of eligible obese patients receive bariatric surgery. There are patients who do not want to undergo surgery or patients who are at higher surgical risk, with contraindications to surgery and/or anesthesia. In addition, some patients with obesity-related comorbidities have a BMI just below the established criteria for bariatric surgery. Moreover, certain patients such as younger people would prefer to lose weight by using non-invasive options. Thus, endoscopic bariatric therapies (EBT), especially intragastric balloons (IGBs), seem to fill the gap between medical and surgical options. Despite the advantages of IGB, such as anatomy preservation, a potentially lower risk of serious complications, and costing less than bariatric surgery, the achieved weight loss is smaller and rather temporary (2, 3). Therefore, other behavioral and pharmacological interventions are important to maintain weight loss. In this paper, we will discuss the current place of IGBs in the treatment of obesity with a particular focus on their efficacy and safety, recent US Food and Drug Administration (FDA) updates, in order to facilitate future decisions on implementing EBT for the individual patient. Other EBTs will not be discussed in this review.
The use of endoscopic bariatric therapies
Endoscopic bariatric devices are generally divided into gastric and small bowel endoscopic therapies. Gastric EBT includes devices that occupy space in the stomach (IGB), devices that remove a portion of the consumed meal (aspiration therapy), and devices that alter gastric anatomy to reduce volume and accommodation (plication, suturing) (tab. 1). Some devices have already been approved by the FDA and several more are currently under investigation (4). All health care providers should be particularly familiar with IGBs which are available worldwide. Weight loss due to IGBs mostly results from increased satiety and delayed gastric emptying.
Tab. 1. Endoscopic bariatric therapies
|Gastric endoscopic bariatric therapies|
|Devices occupying stomach space with the device: Intragastric balloons|
Orbera Intragastric Balloon System (Apollo Endosurgery, Austin, TX)
ReShape Integrated Dual Balloon System (ReShape Medical, San Clemente, CA)
Obalon Balloon System (Obalon Therapeutics, Carlsbad, CA)
Spatz Adjustable Balloon System (Spatz FGIA, Great Neck, NY)
Elipse Balloon (Allurion Technologies, Wellesley, MA)
Devices occupying space by delaying gastric emptying:
Transpyloric Shuttle, TPS (BARONova Inc, San Carlos, CA)
Devices removing excess calories
Aspiration therapy (Aspire Assist System, Aspire Bariatrics, King of Prussia, PA), FDA approved
Devices altering anatomy
Primary Surgery Obesity Endoluminal, POSE Procedure (Incisionless Operating Platform, USGI
Medical, San Clemente, CA)
Endoscopic Sleeve Gastroplasty, ESG (The Overtstitch, Apollo Endosurgery, Austin, TX)
|Small bowel endoscopic bariatric therapies |
|Duodenal-Jejunal Bypass Liner, EndoBarrier (GI Dynamics, Boston, MA)|
Duodenal Mucosal Resurfacing, Revita DMR (Frctyl, Lexington, MA)
Gastroduodenojejunal bypass sleeve, ValentTX Endoluminal Bypass (ValentTX Inc, Hopkins, MN)
Self-assembling magnets for dual-path enternal bypass, Incisionless Magnetic Anastomosis System,
IMAS (GI Windows, Boston, MA)
The American Society for Metabolic and Bariatric Surgery (ASMBS) has added IGB therapy to the list of approved procedures and devices for the treatment of obesity with discussing potential situations where this therapy may be offered. In general, an IGB is indicated for patients with a BMI between 30 and 40 kg/m2 who were not able to lose weight or maintain weight loss with standard noninvasive methods or who refuse to undergo permanent bariatric surgery. IGB can be considered as a bridge therapy for patients who need to lose weight before non-bariatric procedures (e.g. knee or hip replacement) (2, 5).
Currently, there are three types of IGBs having been approved by the FDA from 2015 to 2016: OrberaTM (OrberaTM Intragastric Balloon System, Apollo Endosurgery Inc., Austin, TX), ReShape Integrated Dual Balloon System (ReShape Medical, Inc., San Clemente, CA), and the Obalon System (Obalon Therapeutics, Inc.) (tab. 2) (6-8). In addition, the FDA approved in 2016 the AsspireAssist (Aspire Bariatric Inc., King of Prussia, PA) which removes a portion of the stomach content after eating (tab. 1) (4). The OrberaTM and ReShape balloons were the first IGBs that received approval after the removal of the Garren-Edwards Gastric Bubble (GEB, American Edwards) in 1988 due to several reports that showed a low efficacy and high complications rate including balloon deflation causing bowel obstruction, bleeding gastric ulcers, and gastric perforation (4). The ASMBS estimated that 5,000 IGBs have been implemented since FDA approval, which represents less than 3 percent of the 216,000 bariatric surgeries performed in the United States in 2016 (6). The OrberaTM and ReShape IGBs are placed for a maximum period of 6 months. The Obalon System is intended to remain in the stomach for 6 months from the time of placement of the first balloon. After that time, all balloons must be removed. The indication for IGB according to the instruction of the individual companies are as follows. The OrberaTM Intragastric Balloon System is indicated for patients with a BMI of ≥ 30 and ≤ 40 kg/m2 in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. The Orbera™ IGB is indicated for adult patients who have failed to achieve weight reduction with more conservative alternatives such as a supervised diet, exercise, and behavior modification programs (10). The ReShape Dual Balloon System is indicated in conjunction with diet and exercise for adult patients with a BMI of 30 to 40 kg/m2 and 1 or more obesity-related comorbid conditions and who have failed to achieve weight reduction with diet and exercise alone. The maximum placement period for the ReShape balloon is 6 months (11). The Obalon Balloon System is indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 to 40 kg/m2) who have failed to lose weight through diet and exercise. The system is intended to be used as an adjunct to a moderate intensity diet and behavior modification program (12).
Tab. 2. Intragastric balloons characteristics
|Orbera Intragastric Balloon System|
FDA approved. Implantation time: 6 months.
Saline-filled single silicone balloon system, fill volume: 400-700 mL.
Placement: endoscopic. Removal: endoscopic after aspiration of balloon fluid.
|ReShape Integrated Dual Balloon System|
FDA approved. Implantation time: 6 months.
Saline-filled double silicone balloon system. Fill volume: 375-450 mL/balloon.
Placement: endoscopic. Removal: endoscopic after deflation.
|Obalon Balloon System|
FDA approved. Implantation time: 6 months (from the first balloon administration).
Nitrogen mix gas filled, up to 3 thin polymer balloons Fill volume: 250 mL.
Placement: balloon swallowed in a capsule, confirmation with fluoroscopy.
Removal: endoscopic after deflation.
|Spatz Adjustable Balloon System|
Not FDA approved. Implantation time: 12 months.
Saline-filled silicone balloon system with volume adjustment.
Placement: endoscopic. Removal: endoscopic.
Not FDA approved. Implantation time: 4 months.
Saline-filled balloon made of film. Fill volume: 550 mL.
Placement: balloon swallowed in a capsule, confirmation with fluoroscopy.
Removal: catastrophic valve release to allow complete balloon deflation and passage through
Intragastric balloons in clinical practice
The ASMBS and American Society for Gastrointestinal Endoscopy (ASGE) recommend multidisciplinary care of patients treated with an IGB to support weight loss and subsequent maintenance (2, 3). There are several important issues that should be taken into account when performing EBT in clinical practice in order to achieve maximum benefits with the lowest risks. The institutions offering EBT must have access to several services that will provide proper management of obese patients such as: gastroenterologists trained in bariatric procedures, gastrointestinal endoscopy nurses, bariatric surgeons, anaesthetists, dieticians, and mental health providers. Appropriate patient selection is critical for procedure success itself and weight loss maintenance. The clinical history should be analyzed to assess contraindications and risk of potential complications. Contraindications to an IGB include: prior gastric or bariatric surgery, large hiatal hernia (≥ 5 cm), esophageal motility disorders, esophageal strictures, inflammatory bowel diseases affecting the upper gastrointestinal tract, pregnancy and breastfeeding, potential upper gastrointestinal bleeding conditions (e.g. varices), severe liver disease, gastric mass, concurrent use of anticoagulation therapy or aspirin, coagulopathy, uncontrolled psychiatric disorders, alcoholism or drug addiction, and suspicion of allergy to IGB materials (2, 3, 10-13). In addition, patients should be informed about the necessity of diet and behavior modification not only at the time of balloon therapy but as well as before and after the procedure. Patients should be motivated to lose weight before and after the procedure to achieve long-term benefits. Therefore, IGB therapy should not be offered for patients who are unwilling to participate in an established supervised diet and behavior modification program. The AMBS underlines the importance of informed patient consent. Patients should be informed that IGB therapy is a non-surgical, but invasive procedure, and should receive detailed information about potential adverse events such as: intestinal/gastric outlet/esophageal obstruction, death, nausea, vomiting, abdominal pain, gastroesophageal reflux, injury to the digestive tract during placement or removal of the balloon (ulcers, bleeding, perforation), balloon deflation and its subsequent removal, insufficient or no weight loss, and complications associated with endoscopy or anaesthesia. Particular attention with consultations should be paid to avoid misinterpretation of the procedure. Patients who lack a general understanding of the procedure and its risks and benefits should not be considered for IGB therapy (2, 13). Currently, the FDA recommends patients to participate in a lifestyle program for 6 months when the balloon is placed in the stomach and for 6 months after its removal. All patients should have regular sessions with a dietician before and after the endoscopic procedure. General patient management recommendations are summarized in table 3 (2, 3, 13).
Tab. 3. Intragastric balloon in clinical practice – patient management
|Pre-procedural patient evaluation||Careful selection of patient: medical history, physical examination, screening for obesity-related diseases, commitment to lifestyle change Nutrition assessment: diet history, eating patterns.|
Education for postoperative diet.
Routine laboratory tests: complete blood count, fasting blood glucose, lipid panel, liver profile, kidney function, prothrombin time, urinalysis.
Consider nutritional screening: 25-hydroxy vitamin D, iron, vitamin B12, and folic acid.
Consider psychological evaluation: psychosocial behavioral evaluation by a psychiatrist or psychologist.
Consider if necessary: endocrine and cardiopulmonary evaluation.
|Procedure issues||Post-procedural symptoms (usually first days) management:|
vomiting and nausea: ondansetron (8 mg po tid), metoclopramide (10 mg)
dehydration: ensure adequate fluid intake, intravenous fluid
reflux symptoms: proton pump inhibitor po
Early post-procedural diet recommendation:
Day 1 to 2: clear liquids only (e.g. water weak coffee, tea)
Day 3 to 14: full liquid diet (1000-1200 kcal/d, e.g. low fat yogurt drinks, skim milk, protein shakes)
Day 15 to 21: soft food (1200-1500 kcal/d)
After 21 days: normal textured food
Solid food should be introduce gradually
Recommend 1/2 glass of water 30 minutes before and 30 minutes after eating
Balloon removal at 6 months:
Day 3 to 4 before: full liquid diet
24 to 36 hours before: clear liquid diet
12 hours before: fasting
Concern for spontaneous deflation: patients education, methylene blue in balloon, abdominal radiograph (if necessary)
|Post-procedural patient evaluation||Consider evaluation of laboratory tests and micronutrient status|
Lifestyle intervention (for one year, frequency based on trials: 6 to 13 visits, face-to-face session preferred) including:
diet (dietitian/physician) to reduce calorie intake
exercise (moderate-intensity exercise, ≥ 150 minutes per week for weight loss and 200-300 minutes per week for weight maintenance)
behavioral modification (self-monitoring, slowing the rate of eating, social support, cognitive restructuring, problem solving, relapse intervention)
Pivotal intragastric balloon studies
Powyżej zamieściliśmy fragment artykułu, do którego możesz uzyskać pełny dostęp.
Płatny dostęp do wszystkich zasobów Czytelni Medycznej
1. American Society for Metabolic and Bariatric Surgery: Metabolic and bariatric surgery: fact sheet. 2013; https://asmbs.org/wp/uploads/2014/05/Metabolic+Bariatric-Surgery.pdf.
2. Ali MR, Moustarah F, Kim JJ et al.: American Society for Metabolic and Bariatric Surgery position statement on intragastric balloon therapy endorsed by the Society of American Gastrointestinal and Endoscopic Surgeon. Surg Obes Relat Dis 2016; 12: 462-467.
3. Sullivan S, Kumar N, Edmundowicz SA et al.: ASGE position statement on endoscopic bariatric therapies in clinical practice. Gastrointest Endosc 2015; 82: 767-772.
4. Sullivan S, Edmundowicz SA, Thompson CC: Endoscopic Bariatric and Metabolic Therapies: New and Emerging Technologies. Gastroenterology 2017; 152: 1791-1801.
5. American Society for Metabolic and Bariatric Surgery: Approved procedures and devices; https://asmbs.org/resources/approved-procedures.
6. US Food and Drug Administration: Summary of safety and effectiveness data (SSED) ORBERA Intragastric Balloon System; https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008b.pdf. 2015:1-32.
7. US Food and Drug Administration: Summary of safety and effectiveness data (SSED) ReShape Integrated Dual Balloon System; https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140012b.pdf. 2015:1-43.
8. US Food and Drug Administration: Summary of safety and effectiveness data (SSED) Obalon Balloon System; https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160001b.pdf. 2016:1-46.
9. ASMBS adds intragastric balloon to approved procedures and devices. Connect Official News Magazine of ASMS; http://connect.asmbs.org/february-2018-asmbs-balloon-approval.html.
10. Orbera Intragastric Balloon System. Direction for Use; http://apolloendo.com/wp-content/uploads/2017/06/GRF-00346-00R02.pdf.
11. ReShape Medical: ReShape Integrated Dual Balloon System Instruction for use; https://reshapeready.com/wp-content/uploads/2015/07/ReShape_Instructions_For_Use.pdf.
12. Obalon Balloon System Instruction for Use; http://www.obalon.com/wp-content/uploads/2016/12/P160001.Obalon.BalloonIFU.PhysicianLabeling.IR-10_Response_clean_0908201612.pdf.
13. Papademetriou M, Popov V: Intragastric Balloons in Clinical Practice. Gastrointest Endoscopy Clin N Am 2017; 27: 245-256.
14. US Food and Drug Administration: The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons. February 9, 2017; https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm540655.htm.
15. US Food and Drug Administration: UPDATE: Potential risks with liquid-filled intragastric balloons – Letter to Health Care Providers. August 10, 2017; https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm570707.htm.
16. Tate CM, Geliebter A: Intragastric Ballon Treatment for Obesity: FDA Safety Updates. Adv Ther 2018; 35: 1-4.
17. ASGE/ABE issue response to FDA intragastric balloons warning. August 18, 2017; http://www.bariatricnews.net/?q=news/112798/asgeabe-issue-response-fda-intragastric-balloons-warning.
18. Moore R, Rosenthal R, American Society for Metabolic and Bariatric Surgery: Proposed Addendum to Position Statement on Intragastric Ballon Therapy. January 2018; https://asmbs.org/wp/uploads/2018/02/Balloon-Addemdum-Moore-Rosenthal.pdf.
19. ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee, Abu Dayyeh BK, Kumar N et al.: ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc 2015; 82: 425-38.e5.
20. Gaur S, Levy S, Mathus-Vliegen L et al.: Balancing risk and reward: a critical review of the intragastric balloon for weight loss. Gastrointest Endosc 2015; 81: 1330-1336.
21. Kotzampassi K, Grosomanidis V, Papakostas P et al.: 500 intragastric balloons: what happens 5 years thereafter? Obes Surg 2012; 22: 896-903.
22. Vagas EJ, Rizk M, Bazerbachi F et al.: Medical Devices for Obesity Treatment. Med Clin N Am 2018; 102: 149-163.
23. Genco A, López-Nava G, Wahlen C et al.: Multi-centre European experience with intragastric balloon in overweight populations: 13 years of experience. Obes Surg 2013; 23: 515-521.
24. Popov VB, Ou A, Schulman AR et al.: The impact of Intragastric Balloons on Obesity-Related Co-Morbidities: A Systemic Review and Meta-Analysis. Am J Gastroenterol 2017; 112: 429-439.
25. Vargas EJ, Pesta CM, Bali A et al.: Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population. Clin Gastroenterol Hepatol 2018 Feb 7. pii: S1542-3565(18)30117-4 [Epub ahead of print].
26. Agnihotri A, Xie A, Bartalos C et al.: Real-world safety and efficacy of fluid-filled dual intra-gastric balloon for weight loss. Clin Gastroenterol Hepatol 2018 Feb 23. pii: S1542-3565(18)30171-X [Epub ahead of print].
27. Kumar N, Bazerbachi F, Rustagi T et al.: The influence of the Orbera Intragastric Balloon Filling Volumes on Weight Loss, Tolerability, and Adverse Events: a Systemic Review and Meta-Analysis. Obes Surg 2017; 27: 2272-2278.
28. Zerrweck C, Maunoury V, Caiazzo R et al.: Preoperative weight loss with intragastric balloon decreases the risk of significant adverse outcomes of laparoscopic gastric bypass in super-super obese patients. Obes Surg 2012; 22: 777-782.
29. Coffin B, Maunoury V, Pattou F et al.: Impact of Intragastric Balloon Before Laparoscopic Gastric Bypass on Patients with Super Obesity: a Randomized Multicenter Study. Obes Surg 2017; 27: 902-909.
30. Vicente C, Rábago LR, Ortega A et al.: Usefulness of an intra-gastric balloon before bariatric surgery. Rev Esp Enferm Dig 2017; 109: 256-264.
31. Neto MG, Silva LB, Grecco E et al.: Brazilian Intragastric Balloon Consensus Statement (BIBC): practical guidelines based on experience of over 40,000 cases. Surg Obes Relat Dis 2018; 14: 151-159.
32. Tate CM, Geliebter A: Intragastric Balloon Treatment for Obesity: Review of Recent Studies. Adv Ther 2017; 34: 1859-1875.
33. Marrone AK, Antonino MJ, Silverstein JS et al.: The Regulatory Perspectives on Endoscopic Devices for Obesity. Gastrointest Endosc Clin N Am 2017; 27: 327-341.